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MEETING THE CHALLENGES
OF OUR TIME.

Breakthrough accuracy, flexibility and
efficiency in pathogen testing.

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Detecting Foodborne
pathogens in a
single shift.

AOAC-Certified innovation to
advance Food testing.

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DETECT THE VARIANTS.
REJECT THE BARRIERS.

Identifying COVID-19 mutations
without sequencing.

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GROWING SAFETY
AND EFFICIENCY.

Partnering with labs to evolve
an emerging industry.

PathogenDx creates technology solutions for a new era
of Bacterial, Fungal and Viral testing.
Science makes us
different.
Home to Molecular scientists credited with over 50 patents, PathogenDx invented the Microarray technology to enable multiplex testing of multiple pathogens in a single sample. For human, food, agriculture or the environment, now one test drives simplicity, cost savings and class-leading accuracy.
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Greater certainty at
ultra-rapid speed.
Instead of growing cultures in Petri dishes, DNA-based detection and quantitation delivers maximum detection down to 0.1 CFU for pathogenic organisms. In just 6 hours, laboratories and their customers know the contaminants they need to address.
KEEPING THE FLOW OF BUSINESS
AND TESTING FRICTIONLESS.
With PathogenDx, labs operate at the speed of business, efficiently meeting the testing regulations and minimizing re-testing and reducing economic loss. While healthcare, food & agriculture companies ensure efficient operations. Overall, health threats can be stopped before they start.
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BUILT-IN EFFICIENCIES
FOR LABS.
PathogenDx testing technology is flexible, and can be performed with equipment available in most labs. Additionally, each well in our multiplex microarray is foil sealed, enabling full use of testing consumables in meeting daily capacity, while minimizing waste.
The PathogenDx Solutions Suite

Product Safety Solutions

Description

Clinical

Diagnostics

COVID-19

Variants

RUO-Research

Use Only

Food Safety

Hemp & Cannabis

Pathogens

Detects bacterial and fungal species

This product provides requirements for bacterial and fungal pathogen species level testing for cannabis and Hemp. Overnight enrichment is not necessary and optional dependent on state-level testing regulations. Additional reagents available for LIVE organism testing.

Click for list of specific pathogens

Detect tests are validated down to 1 CFU (Colony Forming Units) detection of Listeria monocytogenes, Listeria spp, Salmonella spp, E. coli (pathogenic and non pathogenic), Pathogenic E. coli genes Stx1/2, Campylobacter spp, Staphylococcus aures, Pseudemonas aeruginosa, and Aspergillus Flavus, Aspergillus Fumigatus, Aspergillus Niger, and Aspergillus Terreus.

COVID-19 testing & surveillance

DetectX-Rv test is based on end-point reverse transcription polymerase chain reaction (RT-PCR) coupled to DNA microarray hybridization for the detection of multiple genes within the SARS-CoV-2 virus.

Viruses including SARS-CoV-2

Intended for the qualitative detection of N1 and N2 regions of SARS-CoV-2 viral genome in nasopharyngeal, nasal, and oropharyngeal swab specimens from individuals suspected of COVID-19 by their healthcare provider. This test is based on an initial reverse transcription polymerase chain reaction (RT-PCR) amplification and subsequent detection of target SARS-CoV-2 molecules by DNA microarray hybridization. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meets requirements to perform high complexity tests

SARS-CoV-2 clade variant detection

Identification of SARS-CoV-2 Clade Variants from a positive COVID-19 PCR test

All known SARS-CoV-2 Clade Variants

Identification of the following Clade Variants: UK (B.1.1.7), South African (B.1.351), Brazillian (P1, P2), California-USA (B.1.429), India (N440K)

Combined Bacterial and fungal detection

For detection of Aspergillus Flavus, Aspergillus Fumigatus, Aspergillus Niger, and Aspergillus Terreus, Pathogenic Ecoli and Salmonella at 1 CFU/g .

Detection of multiple Pathogens down to 1CFU

Dual Hybridization of bacterial and fungal pathogens as DetectX Bacterial and DetectX Fungal. This product will save time, consumables and reporting efforts allowing for faster turnaround time.

Same-Day AOAC-Certified Food Pathogen Detection

Detection of bacterial pathogen species level testing in food matrices. Overnight enrichment or shortened enrichment will be required.

Listeria spp, L. mono, salmonella ...

Detection down to 1 CFU of Listeria spp, Listeria Monocytogenes, Pathogenic Ecoli, Campylobacter and Salmonella Enterica to 1 CFU/g.

Environmental Safety Solutions

"Early warning" Surface & Air pathogen detection

Environmental Screening test for the presence or absence of 30+ bacterial and/or fungal pathogens as well as broad class indicators. This assay can be utilized with multiple sample collection types, including but not limited to food, cannabis and agriculture products, environmental or carcass swabs, air sampling and water sampling.

Over a dozen bacterial and fungal pathogens

Bacterial Organisms
Total Aerobic Bacteria (TAB) - Pan Bacterial
Bile-Tolerant Gram-negative (BTGN)
Total Enterobacteriaceae (ENT)
Salmonella spp./ Enterobacter spp.
Salmonella spp.
Escherichia spp./Shigella spp.
Escherichia coli Pseudomonas spp. Pseudomonas aeruginosa
Listeria spp.
Campylobacter spp.
Xanthomonas spp.
Aeromonas spp.
Staphylococcus spp.
Bacillus spp.

Fungal Organisms
Total Yeast & Mold (TY&M) - Pan Fungal
Fusarium oxysporum Fusarium solani
Mucor spp.
Stachybotrys spp. Golovinomyces spp. (Powdery Mildew)
Alternaria spp.
Aspergillus fumigatus Aspergillus niger Aspergillus flavus
Botrytis spp.
Aspergillus terreus
Penicillium spp./Aspergillus spp. Penicillium spp.
Candida glabrata/Saccharomyces spp.,/Kluyveromyces spp.
Candida albicans/tropicalis
Candida albicans/dubliniensis
Cladosporium spp.
Saccharomyces spp.

"Early warning" Surface & Air SARS CoV-2 detection

The PathogenDx EnviroX-Rv uses endpoint PCR + DNA microarray technology to detect SARS-CoV-2 from stainless steel environmental sample swabs.

Viruses including SARS-CoV-2 and others

Targets N1, N2 and N3 targets of the SARS-CoV-2 viral genome for detection on stainless steel (Does not preclude detection on plastic, rubber and sealed concrete)

Same-Day AOAC-Certified Surface pathogen detection

Performance Tested Method Status by the AOAC Research Institute for the multiplex detection of Salmonella spp., Listeria spp., and L. monocytogenes without an enrichment step. 4 different commonly used food surfaces. The assay is validated down to 1 CFU without the need for sample enrichment. Surface & Air SARS CoV-2 detection

Listeria spp, Listeria monocytogenes and Salmonella

on rubber, plastic, stainless steel and sealed concrete to 1 CFU/gram.

Quantification Solutions

Quantification for bacterial and fungal pathogens

The QuantX test - Bacterial and Fungal assay provides a semi-quantitative analysis of several broad class indicators. The assay can be used in parallel with the DetectX assay, without the need for enrichment and additional sample preparation, to meet all state cannabis regulations. This product can also be used for optional testing of Food applications.

Multiple Yeasts and Molds

Total Aerobic, Bile Tolerant Gram Negative, Enterobacteriaceae/Coliform, and Total Yeast and Mold. from 100 to 100,000 CFU/gram

Live vs. Dead

All Products

Isolation of "live" DNA for pathogen detection

Sample preparation to prevent non-viable cells from being amplified preventing false positives. This product is a supplement to current sample preparation methods.

PARTNERING WITH LEADERS.
A few of our noteworthy partnerships, affiliations and certifications.
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Life Sciences:

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Cannabis:

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Food Safety: